Question 1

Who is the manufacturer of AS/3 AIRWAY MODULE?

Accepted Answer

Datex Division Instrumentarium Corp. filed the 510(k) submission for AS/3 AIRWAY MODULE (K943458).

Question 2

What is the FDA product code for AS/3 AIRWAY MODULE?

Accepted Answer

CBS. It is classified under 21 CFR 868.1620 as a Class 2 device in the Anesthesiology panel.

Question 3

When was AS/3 AIRWAY MODULE cleared by the FDA?

Accepted Answer

Feb 14, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for AS/3 AIRWAY MODULE?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like AS/3 AIRWAY MODULE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K943458
Device Name	AS/3 AIRWAY MODULE
Applicant	Datex Division Instrumentarium Corp.
Product Code	CBS · Anesthesiology
Decision Date	Feb 14, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1620
Device Class	Class 2

AS/3 AIRWAY MODULE

Device Facts

Regulatory Classification

Identification